ANAVEX Phase I Trial Promising as Alzheimers Disease Treatment
Currently, there are somewhere around 80 medications and potential treatments for Alzheimer’s disease in different stages of clinical trials around the world. One, an agent currently called ANAVEX 2-73, has been singled out by the editorial staff at Alzheimer’s Weekly as being one of the most promising.
ANAVEX 2-73 Targets Neurotransmitter Receptor Sites
Per the company’s press release, “ANAVEX 2-73 is the first of a new class of compounds that act through sigma-1 receptor agonism as well as muscarinic cholinergic effects and modulation of endoplasmic reticulum stress thought to trigger a series of intracellular effects which modify ion channel signaling at the mitochondrial level.”
Sigma receptors are a unique family of proteins found mainly in the central nervous system. They are classified into two subtypes: Sigma-1 and Sigma-2. Sigma-1 receptors are involved in the modulation of neurotransmitter receptor function, as well as neurotransmitter release and response. They are also involved in memory and learning processes.
The drug also may help to prevent oxidative stress and apoptosis (cell death) which have also been implicated in the progression of Alzheimer’s disease.
In early pre-clinical trials on animals, Anavex 2-73 has been shown to improve memory and may offer protection to the brain’s neuronal system. The findings of the studies were published in the Journal of Psychopharmacology.
Anavex Life Sciences has now filed for the drug to be entered into human clinical trials, which are conducted in phases. In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
Anavex plans to initiate their Phase I trial using 24 healthy human volunteers, says Dr. Angelos Stergiou, Clinical Research Physician and President of Genesis BioPharma Group. The Phase I study will be carried out in collaboration with the University of Dresden in Germany.
In Phase II trials, the experimental drug or treatment is given to a larger group of people (100-300) to further evaluate its effectiveness and safety. Anavex will start a Phase IIa study in patients with Alzheimer’s and Mild Cognitive Impairment in mid-2011.